Regulatory Guiding Principles


AbleNet follows regulations outlined by different regulatory bodies worldwide to ensure our products are safe, abide by local laws and regulations, and ultimately perform at the highest level.

  • We have certified our assistive technology products classified as medical devices under Europe’s Medical Device Regulation 2017/45 (MDR).
  • Third-party laboratories test our assistive technology products to ensure compliance with CPSIA, RoHS, REACH, FCC, RED, IEC-62638, Bluetooth SIG, and shipping guidelines for lithium-ion batteries. Also, AbleNet conducts a series of tests to validate product durability and functionality.
  • We have implemented rigorous policies and procedures to help safeguard student or client data when funding a QuickTalker Freestyle communication device. Our policies and procedures comply with HIPAA, Medicare, and Medicaid guidelines.